NIH Decision Tool Updated to Incorporate Revised Common Rule
NIH has updated its human subjects research decision tool to reflect changes brought about by the revised Common Rule.
With the NIH tool, researchers answer a series of brief online questions to determine whether a particular study could be considered human subjects research or if it may be exempt from federal regulations. NIH notes that this tool “should not be used as the sole determination of exemption,” but it functions as a starting point for researchers.
Final revisions to the Federal Policy for the Protection of Human Subjects (“revised Common Rule”) were published in January 2017. The updates seek to modernize, simplify, and enhance oversight for human subjects research and include revised informed consent requirements, revised and new exemptions, and the elimination of continuing review for minimal risk studies. Compliance with most of these changes was required beginning January 21, 2019.
Advarra is committed to helping clients better understand the regulatory requirements for IRB review and provides educational resources via the Advarra Resource Library and the “Reference Materials” section of the Advarra Center for IRB Intelligence (CIRBI) Platform.
For more information on the updated decision tool, review this NIH news post.
To find out what level of IRB review your study might require, download the white paper What Level of Review Does Your Study Need? or contact Business Development to discuss the specifics of a new study submission.